Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT04812002
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent
2. Clinically diagnosed as recurrent or drug-resistant trophoblastic tumor
3. After treatment with at least two or more multidrug chemotherapy regimens
4. Survival is expected to exceed 3 months
5. Age ≥18 years, age ≤75 years
6. Karnofsky score ≥60分，ECOG score ≤2分
7. No serious complications
8. Take effective contraceptives during treatment
9. Patients can be followed up as required
10. Blood test within 3 days: ANC≥1.5×109/L, PT ≥100×109/L, Hb≥90g/L, BIL ≤ 1.5 times of the high limit of normal value, ALT/ALST ≤ 1.5 times of the high limit of normal value, BUN and Cr≤ normal value
11. Coagulation function, thyroid function and myocardial enzyme in the normal range
Exclusion Criteria:
1. Previously, he had received anti-PD-1, anti-PD-L1, bevacizumab and other drugs;
2. Within 2 weeks before the first administration, he had received anticancer Chinese patent medicine or immunomodulatory drugs;
3. Within 2 years before the first administration, he had received active autoimmune disease requiring systemic treatment;
4. Were receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to first administration;
5. Clinically uncontrollable pleural effusion/peritoneal effusion is present;
6. Allergic to PD-1 monoantibody, bevacizumab and other active ingredients or excipients；
7. Failure to fully recover from toxicity and/or complications；
8. History of HIV infection, untreated active hepatitis B, and active HCV infection subjects；
9. Live vaccine was administered within 30 days prior to the first dose；
10. Patients with serious or uncontrollable medical conditions who are not suitable for chemotherapy；
11. Participating in clinical trials of other drugs at the same time or 4 weeks before the first administration。
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04812002
Study Brief:
Protocol Section:
NCT04812002